Kornimate/medical-research-clean huggingface dataset:
a study of cnct19 treatment in children and adolescent r/r all patients(pediatric)

Conditions: B-cell Acute Lymphoblastic Leukemia

Summary: this is a multi-center, phase ib/ii trial to evaluate the safety and efficacy of cnct19 treatment in children and adolescent (pediatric) patients with relapsed or refractory b-cell acute lymphoblastic leukemia (r/r b-cell all).

this trial is a multi-center, open label, single-arm, phase ib/ii trial to evaluate the safety and efficacy of cnct19 in children and adolescent(aged 3\~18 years old) patients (pediatric) with r/r b-cell all. the phase ib part of the trial is to evaluate the safety, optimal dose of cnct19, pharmacokinetics/pharmacodynamics(pk/pd)and preliminary efficacy in the treatment of children and adolescent patients with r/r b-cell all. the phase ii part of the trial is to evaluate the efficacy and safety of cnct19 in in the treatment of children and adolescent patients with r/r b-cell all. the study includes screening, pre-treatment (cell product manufacture \& lymphodepletion), cnct19 infusion , safety and efficacy follow-up, and survival follow-up. all subjects who have received cnct19 infusion will be followed for up to 2 years.

Eligibility criteria:
key inclusion criteria: 1. signed written informed consent prior to any study procedures (patient and/or parent or legal guardian) 2. age 3 to 18. weight ≥10kg 3. relapsed or refractory acute lymphoblastic leukemia (all). 4. documentation of cd19 tumor expression demonstrated in bone marrow or peripheral blood within 3 months before screening. 5. bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening. 6. karnofsky (age ≥ 16 years) performance status ≥ 70 or lansky (age \< 16 years) performance status ≥ 50 at screening 7. organ function requirements: all patients must have adequate renal and liver functions key exclusion criteria: 1. active central nervous system (cns) involvement by malignancy. 2. isolated extra-medullary disease relapse. 3. patients with burkitt's lymphoma/leukemia, mixed phenotypic acute leukemia and chronic myelogenous leukemia in blast crisis 4. history of concomitant genetic syndrome 5. patients with acute graft-versus-host disease (gvhd) or moderate-to-severe chronic gvhd within 4 weeks before screening. 6. active systemic autoimmune disease 7. known infection with human immunodeficiency virus (hiv) or chronic infection with hepatitis b virus (hbsag positive) or hepatitis c virus (anti-hcv positive). 8. patients with active infections at screening. 9. patients who received specified chemotherapy before cnct19 infusion 10. radiotherapy before cnct19 infusion: non-cns site of radiation completed \< 4 weeks prior to cnct19 infusion; cns directed radiation completed \< 8 weeks prior to cnct19 infusion. 11. donor lymphocyte infusion (dli) must be stopped \> 6 week prior to cnct19 infusion. 12. has had treatment with any prior car-t therapy. 13. life expectancy \< 3 months.

Keywords: cnct19 cluster of differentiation antigen 19(cd19) cd19-directed car-t cells
lifestyle intervention for obstructive sleep apnea in women

Conditions: Obstructive Sleep Apnea

Summary: obesity is a major risk factor for obstructive sleep apnoea (osa), the most common sleep-disordered breathing related to neurocognitive and metabolic syndromes, type ii diabetes, and cardiovascular diseases. although strongly recommended for this condition, there are no studies on the effectiveness of an interdisciplinary weight loss and lifestyle intervention including nutrition, exercise, sleep hygiene, and smoking and alcohol cessation in women. interapnea-women is a randomized controlled trial with a two-arm parallel design aimed at determining the effects of an interdisciplinary tailored weight loss and lifestyle intervention on osa outcomes. the study will include 180 females aged 18-65 with a body mass index of ≥25 kg/m2 and severe to moderate osa randomly assigned to usual care (i.e., continuous positive airway pressure), or interdisciplinary weight loss and lifestyle intervention combined with usual care. outcomes will be measured at baseline, intervention end-point, and six-month post-intervention, including apnoea-hypopnoea index (primary outcome), other neurophysical and cardiorespiratory polysomnographic outcomes, sleep quality, daily functioning and mood, body weight and composition, physical fitness, blood biomarkers, and health-related quality of life. interapnea may serve to establish a cost-effective treatment not only for the improvement of osa and its vast and severe comorbidities, but also for a potential remission of this condition.


Eligibility criteria:
inclusion criteria: * previous clinical diagnosis of moderate/severe osa (ahi \> 15) * female patients aged between 18-65 years. * body mass index \> 25 kg/m2. * use of cpap. * motivation to participate in the study. * signed informed consent form. exclusion criteria: * sleep disorder other than osa. * clinically significant psychiatric, neurological, or medical disorders other than osa. * use of prescription drugs or clinically significant drugs affecting sleep.
pathophysiological mechanisms of hepatopulmonary influence in the fontan circulation

Conditions: Children With a Univentricular Heart Undergoing Surgery for Creation of a Fontan Circulation

Summary: randomisation between postoperative administration of an ace-inhibitor or not.

children that are undergoing elective surgery for the creation of a fontan circulation will be randomised to postoperative administration of an ace-inhibitor or not. determination of aldosteron, renine and adh in serum preoperatively and 1h, 12h and 5 days postoperatively.

Eligibility criteria:
inclusion criteria: * all consecutive children with a univentricular heart disease undergoing elective surgery for creation of a fontan circulation * parents have agreed with the study after informed consent exclusion criteria: * urgent / emergent surgery * preoperative use of an ace-inhibitor
evaluation of the links between sleep disorders and the risk of suicide attempt

Conditions: Attempted Suicide

Summary: several studies have demonstrated an association between sleep disorders such as insomnia and nightmares to suicidal ideations and behaviors. nevertheless, some of these studies are methodologically questionable especially in the exploration of sleep disorders. furthermore, confounding factors such as depressive symptomatology are not controlled and the measurement of suicidal behavior has often been taken into account as a historical measure, not as a current event, which introduces uncertainties and a lack of precision regarding the temporality of the phenomena. today, while the links between sleep disorders and suicidal risk are well known, we have a lack of information on the importance and the role of sleep disorders as a precipitating factor. indeed, few studies have evaluated the temporal link between sleep disorders and suicidal acts. the objective of this study is to evaluate the links between acute and chronic sleep disorders and the risk of suicide attempt

pilot, prospective, monocentric case-control study. there are 2 groups of subjects : * group of patients who have made a suicide attempt * control group with only suicidal ideas first visit v1 is performed within the first 72 hours of hospitalization. a re-assessment is scheduled 1 month after (v2). at v1, collected parameters are : chronic sleep disorders, chronotype, specific sleep disorders in posttraumatic stress disorder, nightmares and the distress associated, childhood trauma, cognitive dysfunction, suicidal ideation and psychopathologic assessment. at v2, we assess evolution of sleep disturbances and suicidal ideation.

Eligibility criteria:
inclusion criteria criterion specific to the studying group : - subjects hospitalized and whose indication of hospitalization is a suicide attempt by voluntary drug intoxication or phlebotomy during the last 72 hours, without any history of attempted suicide criterion specific to the control group: - subjects hospitalized since less than 72 hours, and whose indication of hospitalization is the presence of suicidal ideas, without any history of attempted suicide exclusion criteria: * pregnant of lactating women * diagnosed dementia pathology * proven intellectual disability * patient whose physical or mental state does not allow the passing of the tests of the study * under protective measures (guardianship/supervision) * refusal to participate in the study * diagnosed with chronic or severe psychiatric illness (psychotic disorder, bipolarity)

Keywords: suicide suicidal ideation sleep disorder
management of non convulsive status epilepticus

Conditions: Status Epilepticus

Summary: non convulsive status epilepticus is a persistent change in behavioural and or mental process from baseline associated with continuous epileptiform activity in electroencephalograph,it occur in about 50 percent in patients with coma and convulsions and in 8-13 percent in intensive care unit patients

early recognition and treatment of non convulsive status epilepticus are essential to optimize response to treatment and to prevent neurological sequelae, over diagnosis and aggressive use of anticonvulsants can contribute to morbidity and mortality.it displays great diversity in response to anticonvulsants,therefore treatment in intensive care units is required for selected cases .the aetiology and clinical forms are strong predictors for the overall prognosis.treatment is poorly understood and follows the standard regimen for convulsive status epilepticus

Eligibility criteria:
inclusion criteria: * patients who have generalized tonic colonic convulsions and prolonged post ictal state more than 30 minutes * patients presented with un explained psychic or speech disorder * patients presented with stupor or confusion * patients presented with un explained coma exclusion criteria: * patients with progressive neurological disease * patients with severe cerebral anoxia * patients with liver or hepatic impairment
agomelatine in depressed patients with fibromyalgia

Conditions: Major Depression; Fibromyalgia

Summary: depression and unrefreshed sleep are frequent in patients with fibromyalgia. agomelatine is a new antidepressant with sleep-promoting properties. the objective of this study include the assessment of agomelatine therapy in patients with depression and fibromyalgia both on the severity of depressive symptomatology and sleep quality.

one of the most frequent comorbidities of fibromyalgia is major depression. agomelatine is a new antidepressant whose mechanims of action include both agonism at melatonin receptores and 5-ht2c blocking properties which, in addition to antidepressant efficacy, has shown sleep-improving properties. as unrefreshed sleep is a common symptom in fibromyalgia we hypothetized that agomelatine treatment of patients with concomitant depression and fibromyalgia could improve both depressive symtomatology and sleep quality. thus, the objectives of the present study are the following: * to assess the effectiveness and tolerability of agomelatine on the severity of depressive symptomatology in patients with fibromyalgia and concomitatnt depresssion * to evaluate the effect of agomelatine treatment on sleep quality in these patients

Eligibility criteria:
inclusion criteria: * adult patients * diagnosed of fibromyalgia according to the american college of rheumatology criteria * diagnosed of major depression according to the dsm-iv criteria with a bdi-ii score equal or higher tahn 20 exclusion criteria: * other psychiastric concomitant illness * pregnancy or lactation * patients previously treated with agomelatine with little or no effect

Keywords: major depression fibromyalgia agomelatine becks' depression inventory (bdi) pittsburgh's sleep quality index (psqi)
sb497115 (oral thrombopoietin receptor agonist) versus placebo in adults with thrombocytopenia due to hepatitis c

Conditions: Hepatitis C, Chronic; Hepatitis C; Thrombocytopenia

Summary: sb497115 is an oral agent which activates the thrombopoietin receptor and increases platelet counts in healthy volunteers. this study is examining several different doses of sb497115 as a treatment for patients with chronic hepatitis c-related thrombocytopenia who are potential candidates for antiviral treatment with pegylated interferon and ribavirin. the study will be conducted in two phases, parts 1 and 2. in part 1, study subjects will be randomized to 4 weeks of sb-497115-gr or placebo administered daily without antiviral therapy. subjects who successfully complete part 1 (platelet count 70,000/µl for pegasys and platelet count 100,000/µl for peg-intron) will then proceed to part 2. in part 2, subjects will receive an additional 8 weeks of sb-497115-gr or placebo administered daily with antiviral therapy.

a double-blind, randomized, placebo-controlled, multi-centre, dose-ranging, parallel group, phase ii study to assess efficacy, safety/tolerability, and pharmacokinetics of a thrombopoietin receptor agonist, sb-497115-gr, when administered as 30, 50, and 75 mg once daily for 12 weeks in subjects with chronic hepatitis c-related thrombocytopenia who are potential candidates for antiviral treatment with pegylated interferon and ribavirin.

Eligibility criteria:
inclusion criteria: * chronic low platelet count between 20,000 and \<70,000/µl. * prior liver biopsy indicating chronic hepatitis within the previous 5 years or radiographic evidence of cirrhosis and / or endoscopic evidence of non-bleeding esophageal or gastric varices. exclusion criteria: * history of heart attack or abnormal heart function. * history of thrombosis within 1 year. * history of alcohol or drug abuse or dependence within 1 year. * use of aspirin, aspirin-containing compounds, salicylates, antacids. * history of hiv infection or active infection with hepatitis b or c. * females who are pregnant. * patients using non-steroidal anti-inflammatory drugs during the study and within 3 weeks prior to starting the study.

Keywords: thrombopoietin platelets hepatitis c-related thrombocytopenia hepatitis c
mri study after arterial switch operation in patients with transposition of the great arteries

Conditions: Transposition of Great Vessels; Surgery

Summary: this study involves adolescents operated with arterial switch procedure for transposition of the great arteries during the neonatal period. the purpose is to evaluate the coronary arteries and direct and indirect findings of coronary artery disease/complications with 3 tesla magnetic resonance imaging.

this study involves adolescents operated with arterial switch procedure for transposition of the great arteries during the neonatal period. the patients were operated with two different methods of re-implantation of the coronary arteries ("trap-door"/non-"trap-door", see description below).

Eligibility criteria:
inclusion criteria: * clinical diagnosis of transposition of the great arteries with or without ventricular septum defect * surgically corrected during neonatal period with arterial switch procedure partial or total exclusion criteria: * heart arrhythmias * known allergic reaction to gadolinium based contrast media * reduced renal function (below 60 ml/min/1,73m2)

Keywords: child, adolescent coronary artery disease magnetic resonance imaging
study of the impact of indacaterol (onbrez®) on the individual lives and health status of patients with copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: a prospective observational multi centre research study in gp practices clustered within up to 10 uk primary care trusts.


Eligibility criteria:
inclusion criteria: * patients with active diagnosis of copd, confirmed by spirometry documented in medical notes exclusion criteria: * patients who are currently receiving other maintenance therapy (except lama) for copd. * patients previously prescribed indacaterol.

Keywords: copd
rotem in sepsis trauma outcome in intensive care

Conditions: Sepsis - to Reduce Mortality in the Intensive Care Unit; Trauma Coagulopathy

Summary: this prospective observational study aims to investigate the ability of advanced rotem analysis using principal component analysis (pca) to detect early signs of disseminated intravascular coagulation (dic) and trauma-induced coagulopathy (tic) in hospitalized patients with sepsis or trauma. standard coagulation tests and rotem measurements will be collected and analyzed in relation to clinical outcomes.


Eligibility criteria:
inclusion criteria: trauma patients: trauma alarm activated at hospital admission new injury severity score (niss) \> 15 transfer to hospital within 7 days of trauma with niss \> 15 sepsis patients: meeting sepsis-3 criteria receipt of intravenous beta-lactam or aminoglycoside antibiotics within 48 hours of admission control group: patients undergoing elective surgery without expected coagulopathy exclusion criteria: trauma patients: isolated chronic subdural hematoma no underlying traumatic event despite trauma alarm age \<18 years sepsis patients: age \<18 years control patients: ongoing anticoagulant treatment life-threatening illness (asa iv-v) age \<18 years

Keywords: sepsis rotem trauma coagulopathy
follistatin levels in metabolically healthy and unhealthy obese individuals

Conditions: Obesity

Summary: there is no clear boundary on which obese individuals should be considered metabolically healthy and which should be considered metabolically unhealthy. it is also not very clear whether the individuals who are considered metabolically healthy will remain healthy in the future. the objective of this study was to assess potential disparities in serum follistatin levels between these two distinct groups. furthermore, the study sought to investigate whether this disparity could serve as a reliable indicator for distinguishing between metabolically healthy and unhealthy obese individuals.

individuals with similar body mass indexes may have different metabolic health and cardiovascular risks. research shows that some individuals with comparable body mass index (bmi) are metabolically healthy and have a lower risk of cardiovascular issues, while others are metabolically unhealthy and have a higher risk. studies indicate that the lifestyles of metabolically healthy and unhealthy obese individuals, such as diet, physical activity, and sleep patterns, do not differ significantly, even though the individuals have similar levels of total or subcutaneous adiposity. however, it has been shown that metabolically healthy obese individuals tend to have lower levels of visceral adiposity compared to unhealthy ones. patients with bmi≥30, who applied to the internal medicine clinic, were included in the study. among these patients, those without criteria of metabolic syndrome other than an increase in waist circumference (blood pressure ≥130/85 mmhg, fasting blood sugar ≥100 mg/dl, triglycerides ≥150 mg/dl, hdl-cholesterol \<40 mg/dl in men and \<50 mg/dl in women) and without prediabetes were defined as metabolically healthy obese individuals. those with at least 1 metabolic syndrome criterion other than an increase in waist circumference were classified as metabolically unhealthy obese individuals. the participants' fasting blood sugar levels, hba1c levels, insulin levels, lipid panel results, liver enzymes levels,urea levels, creatinine levels, whole blood count, and thyroid hormones were examined. anthropometric measurements including height,weight and waist circumference were also taken for each individual. participants were then invited back to repeat follistatin levels.

Eligibility criteria:
inclusion criteria: * having given consent to the study * being over 18 years of age * being under 60 years of age * body mass index \>=30 kg/m2 exclusion criteria: * antidiabetic medication usage * obesity surgery * antihypertensive medication usage * those receiving lipid-lowering therapy * pregnant women * those with hypo/hyperthyroidism * steroid use * benign/malignant tumors * advanced liver disease * secondary causes of obesity
safety and efficacy of repeat use of picato® 0.05% in the treatment of anogenital warts

Conditions: Anogenital Warts

Summary: an exploratory open label, single treatment trial of anogenital warts with picato® repeated up to 2 times with two weeks intervals.

the purpose of the present trial is to explore the safety, tolerability and efficacy when treating gw with picato® 0.05% gel. the primary outcome measures will be related to safety and tolerability and consists of severity of any local reactions in the treated area; treatment-related adverse events (aes) and serious aes.

Eligibility criteria:
inclusion criteria: * 1. a clinical diagnosis of external anogenital/perianal warts with at least 2 warts and no more than 20 warts located in one or more of the following anatomic locations: 1. in both sexes: inguinal, perineal, and perianal areas 2. in men: penis shaft, scrotum, glans penis and foreskin 3. in women: on the vulva * 2. subjects has a total wart areas of at least 10 mm2, but not more than 500 mm2 * 3. female subjects of childbearing potential must be confirmed not pregnant by a negative urine pregnancy test prior to trial treatment exclusion criteria: * 1. subject has received any topical and/or destructive treatments for external anogenital warts within 4 weeks (within 12 months for imiquimod and within 12 weeks for sinecatechins) prior to enrolment * 2. subject suffer from any of the following conditions: 1. known human immunodeficiency virus (hiv) infection 2. an outbreak of herpes genitalis in the wart areas within 4 weeks prior to enrolment 3. has internal (rectal urethral, vaginal/cervical) warts that require or are undergoing treatment 4. has a dermatological disease (e.g. psoriasis) or skin condition in the wart areas * 3. subjects using systemic virostatic compounds or immunosuppressive medication within 30 days prior to enrollment * 4. prior quadrivalent hpv vaccination
reverse-engineering of exclusive enteral nutrition (re-een) in crohn's disease: a multi-center trial

Conditions: Crohn Disease

Summary: this study will compare the tolerability and efficacy of conventional formula exclusive enteral nutrition (een) and whole-food blended smoothie een by enrolling a total of 60 participants with newly diagnosed pediatric crohn's disease (cd). participants will be provided either commercial formula or guided on the preparation of the home-blended smoothie. these participants will be given a specific recipe, blender, and be provided the food components to the smoothie. the study will total 8 weeks and will assess tolerance, clinical outcomes, stool microbiome, and quality of life.


Eligibility criteria:
inclusion criteria: * age 8 -21 years old. * diagnosis of crohn's disease within 24 months * elevation in objective inflammatory markers at enrollment: c-reactive protein (crp), esr, or fecal calprotectin * active crohn's disease, as defined by pediatric crohn's disease activity index (pcdai) ≥10. * participant capable of giving informed consent, or if a minor the parent/guardian is capable of giving informed consent. exclusion criteria: * history of surgery for crohn's disease. * perianal disease as part of crohn's disease phenotype. * recent use of: * corticosteroids (within 4 weeks), * dose adjustment of immunomodulator (within 8 week) * azathioprine 4 weeks prior to study final visit (week 8) * start or adjust methotrexate 3 weeks prior to final study visit. * prior use of biological medication * prior treatment with een or other dietary therapy for crohn's disease. * prior treatment with antibiotics for crohn's disease. * known allergies to any of the food components in the smoothie. * admission to hospital due to severity of crohn's disease and associated symptoms. * unwillingness to provide informed consent.

Keywords: crohn's inflammatory bowel disease cd